Overview

START-J: SiTAgliptin in eldeRly Trial in Japan

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.
Phase:
N/A
Details
Lead Sponsor:
Japan Association for Diabetes Education and Care
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Glimepiride
Sitagliptin Phosphate